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Investigator(s):
Steven A. Rosenberg, M.D., Ph.D. Principal Investigator Phone: 1-866-820-4505 (Toll Free) ncisbirc@mail.nih.gov
Referral Contact(s):
Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

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Primary Eligibility:

• Metastatic cancer that expresses NY-ESO-1
• Patients with melanoma or renal cell cancer must have previously received high-dose aldesleukin AND have either progressive or recurrent disease
• Patients with any other histologies must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease AND have either progressive or recurrent disease
• HLA-A*0201 positive
• Recovered from all prior therapy
• No concurrent systemic steroid therapy
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months after completion of study treatment
• HIV, hepatitis B, and hepatitis C negative
• No coagulation disorders
• No contraindication for high-dose aldesleukin administration

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Study Outline:

Patients are stratified according to histology (melanoma or renal cell cancer vs other cancers).

Leukapheresis and cell preparation:
• Patients undergo leukapheresis to obtain peripheral blood mononuclear cells
• Cells are then genetically modified and grown in the laboratory

Lymphodepleting preparative regimen:
• Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6 and fludarabine phosphate IV over 30 minutes on Days -5 to -1

Cell infusion:
• Patients receive anti-ESO-1 cells IV over 20–30 minutes on Day 0 and filgrastim (G-CSF) subcutaneously daily beginning on Day 1 and continuing until blood counts recover

High-dose aldesleukin:
• Patients receive high-dose aldesleukin IV over 15 minutes 3 times daily on Days 0–4 (maximum of 15 doses)


• Patients who have a partial response to treatment and then stabilizes and have evaluable disease, or have stable disease that subsequently progresses, may receive another course of treatment beginning no earlier than 6–8 weeks after completion of aldesleukin



• Blood samples are collected periodically for immunologic tests



• After completion of study therapy, patients are followed periodically for 15 years

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/29/09
Updated: 5/14/09